Study of Nivolumab and Ipilimumab for Patients with Advanced Kidney Cancer and Intermediate or Poor Risk Factors

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What is this study about?

This clinical trial is focused on studying treatments for Advanced Renal Cell Carcinoma, a type of kidney cancer that has spread and is not suitable for surgery or radiation. The study involves two treatments: Nivolumab and Ipilimumab. Nivolumab is a medication that helps the immune system fight cancer, and Ipilimumab is another drug that boosts the immune system’s response to cancer cells. The trial will compare the effects of using Nivolumab alone versus using it in combination with Ipilimumab.

The purpose of the study is to understand how well these treatments work in patients who have not received any previous treatment for their advanced kidney cancer and have certain risk factors. Participants will receive either the combination of Nivolumab and Ipilimumab or Nivolumab alone. Some participants may receive a placebo. The study will monitor the progress of the disease and the response to the treatment over time.

Throughout the study, participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which the health and response of the participants will be closely observed. The goal is to determine which treatment option is more effective in managing the cancer and improving the patients’ health outcomes.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of advanced kidney cancer with specific risk factors.

Imaging tests such as CT or MRI are used to measure the disease according to specific criteria.

2 randomization

Participants are randomly assigned to one of two groups: one receiving a combination of nivolumab and ipilimumab, and the other receiving nivolumab alone.

3 treatment administration

The treatment involves intravenous administration. Nivolumab is given as a solution for infusion, and ipilimumab is provided as a concentrate for solution for infusion.

The frequency and dosage are determined by the study protocol and are administered under medical supervision.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and laboratory evaluations.

The study aims to evaluate progression-free survival and overall response rate, among other outcomes.

5 completion of study

The study is expected to conclude by March 2025. Participants will continue to be monitored for outcomes such as overall survival and any adverse effects.

Who Can Join the Study?

  • The patient must have a confirmed diagnosis of renal carcinoma. This is a type of kidney cancer, and it should have a clear cell component, which is a specific type of cell found in this cancer. It may also have sarcomatoid features, which means the cancer cells look like a type of tissue called sarcoma.
  • The cancer must be advanced, meaning it cannot be cured with surgery or radiation, or it must be metastatic, which means it has spread to other parts of the body.
  • The patient must have a measurable disease. This means the cancer can be measured using imaging tests like a CT scan or MRI. These are special types of scans that take detailed pictures of the inside of the body.
  • The patient should not have received any systemic therapy for renal cell carcinoma before. Systemic therapy is treatment that travels through the bloodstream to reach cancer cells all over the body.
  • The patient must be considered intermediate or poor risk according to the International Metastatic RCC Database Consortium (IMDC). This is a way to classify how serious the cancer is based on certain factors.
  • Both male and female patients can participate.
  • The study includes patients who may be considered part of a vulnerable population. This means they might need extra protection or care during the study.

Who Cannot Join the Study?

  • Patients with other types of cancer besides Advanced Renal Cell Carcinoma cannot participate. This is a type of kidney cancer.
  • Patients who have had previous treatments that might interfere with the study drugs are not eligible.
  • Patients with certain health conditions that could make the study unsafe for them are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with certain heart conditions that could be worsened by the study drugs are excluded.
  • Patients who are participating in another clinical trial at the same time are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Medical University Of Vienna Vienna Austria
Medical University Of Graz Graz Austria
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
MD Anderson Cancer Center Madrid Spain
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Hopital Prive Toulon Hyeres Sainte Marguerite Hyeres France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
General University Hospital Of Larissa Larissa Greece
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Hospital Universitario Reina Sofía Cordoba Spain
Virgen del Rocío University Hospital Sevilla Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universidade De Santiago De Compostela Santiago De Compostela Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda USL Toscana Sud Est Arezzo Italy
Universita Degli Studi Di Brescia Brescia Italy
Immobiliere De Nancy Nancy France
Fakultni Thomayerova nemocnice Prague Czechia
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Atmniqo Oilocpcogtq Uafhbuwbfepwo Phkvh Parma Italy
Hfgztuwb Uzgffnerqdwht Mcaubua Dv Vwlnuseyfd Santander Spain
Pcpq Tpgcz Hugyhkky Ucniarrspjog Sabadell Spain
Nmbmifem Cvtcsxce dgu Dohqrzweapfv Valenciennes France
Bwjwtguw Uhvudyzwuf Hxjgcpkk Cntiwo Besançon France
Avvdcs Miznkzu Ccwzvt Spde Thessaloniki Greece
Nelfgpxj Ixexcmxz Oxarkpwir Ind Mikll Saqwtmcgktlklcqbpstwvrfhqqjz Ianqgfwi Bfqmpthx Cracow Poland
Cffwtq Hivbmrcqruj Rqwkixxw Dcjaitfrryyklt Angers France
Hxfrapwu Vjjn dyrrlvjd Barcelona Spain
Ixteybmo Pjxlpriifdmfajw Cetvsc Ccjekr Marseille France
Hveosowz Uhkkeyshvokicz Sgsjvzbqsp &fuwwec Hxjxmia dm Hatfaqkgxun STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
24.06.2019
Czechia Czechia
Not recruiting
24.06.2019
France France
Not recruiting
24.06.2019
Greece Greece
Not recruiting
24.06.2019
Italy Italy
Not recruiting
24.06.2019
Poland Poland
Not recruiting
24.06.2019
Romania Romania
Not recruiting
24.06.2019
Spain Spain
Not recruiting
24.06.2019

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to treat advanced renal cell carcinoma. It works by helping the immune system recognize and attack cancer cells more effectively. Nivolumab is often used in patients who have not received prior treatment for their cancer.

Ipilimumab is another medication used in combination with Nivolumab in this trial. It also helps the immune system fight cancer by targeting a different pathway than Nivolumab. When used together, these medications aim to enhance the body’s ability to combat cancer cells in patients with advanced renal cell carcinoma.

Investigated diseases:

Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors – This is a type of kidney cancer that has progressed to an advanced stage, meaning it has spread beyond the kidney to other parts of the body. It is characterized by the presence of intermediate or poor-risk factors, which can include specific clinical features or laboratory findings that suggest a more aggressive disease course. The cancer cells in renal cell carcinoma originate in the lining of the small tubes in the kidney. As the disease advances, it can lead to symptoms such as blood in the urine, pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some cases growing slowly while others may spread more rapidly.

Trial ID:
2023-508264-29-00
Protocol code:
CA209-8Y8
Trial Phase:
Therapeutic confirmatory (Phase III)

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